Space Maintainers Lab
Form 483 issued October 3, 2024 · Chatsworth, California
- Inspection
- Oct 1 – Oct 3, 2024
- Investigator
- Sarah A. Hassas
- Observations
- 2
- Pages
- 3
- FEI number
- 2082148
In short: On October 3, 2024, FDA issued a Form 483 with 2 observations to Space Maintainers Lab in Chatsworth, California (FEI 2082148) after an inspection that ran Oct 1 – Oct 3, 2024. The investigator was Sarah A. Hassas. Most observations concern records & documents and management controls; the most-cited regulation is 21 CFR 820.184 (device history record).
At a glance
Records & documents and management controls account for 2 of 2 observations.
Most cited: 21 CFR 820.184 (1×) · 820.25(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for device history records…
- 02
Procedures for training and identifying training needs have…
This inspection in context
Sarah A. Hassas
5 documents · 2015–2026
Cites ISO 13485:2016 Clause 7.3.10 (definitions) more than any other section. Most of their documents are for sites in California.
The firmSpace Maintainers Lab history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.184
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Space Maintainers Lab?
FDA listed 2 observations on this Form 483, mostly about records & documents and management controls. The most-cited regulation is 21 CFR 820.184 (device history record). The opening words of each observation are shown on this page.
Who inspected Space Maintainers Lab?
Sarah A. Hassas is named on this Form 483, for the inspection of Oct 1 – Oct 3, 2024. Each investigator has a profile showing what they cite most.
When was Space Maintainers Lab inspected by FDA?
The inspection ran Oct 1 – Oct 3, 2024, and the Form 483 is dated October 3, 2024.
How do I get the full Form 483 for Space Maintainers Lab?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.